IMMUNO-IM— 510(k) K853105
Substantially EquivalentImmunostics Co., Inc.
FDA 510(k) clearance K853105 for IMMUNO-IM, Substantially Equivalent on 1985-09-03. Applicant: Immunostics Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Immunostics Co., Inc.
- Product code
- Code KTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5640
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Metuchen, NJ, US
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